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TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005 November 10, 2005

TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

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Page 1: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

TC 1600 Biotechnology and Pharmaceutical

Customer Partnership Meeting

John Doll - Commissioner for Patents

November 10, 2005November 10, 2005

Page 2: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

22

Contact InformationContact Information

John Doll

Commissioner for Patents

e-mail: [email protected]

Phone: 571 272 8800

Page 3: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

Application FilingsApplication Filings andand

Examiner ProductionExaminer Production

Page 4: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

44

UPR Applications FiledUPR Applications Filed

FY 05 plan 375,080

(7% above FY 04)

383,000 as of 10/30/05 (preliminary)

Current projection1.7% over plan

0

50000

100000150000

200000

250000

300000350000

400000

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

Page 5: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

55

FY 04FY 05 Target

FY 05

UPR1 FAOM2 288,315 297,614 297,287

UPR Disposals3 287,188 295,456 279,345

UPR Production Units4 287,752 296,535 288,316

PCT Production Units5 16,882 22,916 15,147

ProductionProduction

1 “UPR” = Utility, Plant, and Reissue Applications.2 “FAOM” = First Action on the Merits – first action count by an examiner after the filing of an application (does not include

restrictions or other miscellaneous actions).3 “Disposal” = An examiner allowance, abandonment, or disposals following a board decision.4 “Production Unit” = First action count plus disposal count divided by 2.5 “PCT” = Patent Cooperation Treaty. PCT applications are processed differently and tracked separately from US National stage

applications. For FY 05, 15,147 PU’s is 35,389 processed applications.

Page 6: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

. . . vs the Backlog. . . vs the Backlog

PENDENCYPENDENCY

Page 7: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

77

FY 05 Patent PendencyFY 05 Patent Pendency (as of 10/1/2005) (as of 10/1/2005)

Technology CenterAverage 1st Action

Pendency (months)1Average Total

Pendency (months)2

1600 - Biotechnology and Organic Chemistry 23.0 32.3

1700 - Chemical and Materials Engineering 19.7 29.7

2100 - Computer Architecture Software and Information Security 32.7 43.5

2600 – Communications 30.5 42.3

2800 - Semiconductor, Electrical, Optical Systems 14.5 24.9

3600 - Transportation, Construction, Electronic Commerce 18.4 26.9

3700 - Mechanical Engineering, Manufacturing and Products 18.3 26.3

UPR Total (as of 10/1/2005) 21.1 29.1

FY 05 Target 20.7* 31.01 “Average 1st action pendency” is the average age from filing to first action for a newly filed application, completed during July-September FY 2005.2 “Average total pendency” is the average age from filing to issue or abandonment of a newly filed application, completed during July-September FY 2005.* Assuming current input and output estimates, the agency should achieve first action pendency of 21.3 months by the end of FY 2005 and total pendency of 30.2 months.

Page 8: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

88

First Action Pendency by Art AreasFirst Action Pendency by Art Areas

High Pendency Art AreasPendency

1

(months)Low Pendency Art Areas

Pendency1

(months)1640 – Immunology, Receptor/ Ligands, Cytokines, Recombinant Hormones, and Molecular Biology

27.41620 – Heterocyclic Compounds and Uses

16.1

1764 – Distillation, Mineral Oil and Hydrocarbons

28.7 1752 – Radiation Imagery 11.6

2123 – Simulation and Modeling, Emulation of Computer Components

41.62125 – Manufacturing Control Systems and Chemical/ Mechanical/Electrical Control

21.4

2617 – Interactive Video Distribution 45.32636 – General Electrical Communication

18.2

2836 – Control Circuits 25.6 2833 – Electrical Connectors 8.0

3628 – Finance & Banking, Accounting 48.4 3643 – Animal and Plant Husbandry 11.8

3762 – Body Treatment, Kinestherapy, and Exercising

27.5 3742 – Thermal Combustion Technology 10.6

1 “Average 1st action pendency” is the average age from filing to first action for a newly filed application, completed during

July-September FY 2005.

Page 9: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

99

Inventory by Art ExamplesInventory by Art Examples

High Inventory Art AreasMonths of Inventory*

Low Inventory Art AreasMonths of Inventory*

1614, 1615, and 1617 – Drugs, Bio-affecting and Body Treatment

57-65 1620 – Organic Chemistry 18

1753 – Radiation Imagery 391734 – Adhesive Bonding and Coating Apparatus

13

2127 – Computer Task Management 542125 – Manufacturing Control Systems and Chemical/ Mechanical/Electrical Control

13

2611 – Interactive Video Distribution 882651, 2653 – Information Storage and Retrieval

14

2836 – Control Circuits 42 2831 – Electrical Conductors 8

3620 – Business Methods 27 – 106 3651 – Conveying 11

3731 and 3737 – Medical Instruments, Diagnostic Equipment

44-513742 – Thermal and Combustion Technology

8

*The number of months it would take to reach a first action on the merits (e.g., an action addressing patentability issues) on a new application filed as of Jan 2005 at today’s production rate. Today’s production rate means that there are no changes in production due to hiring, attrition, changes to examination processing or examination efficiencies, and that applications are taken up in the order of filing in the given art unit/area. Of course, USPTO is taking aggressive steps to ensure changes that will significantly lower the inventory rates in high-inventory art areas.

Page 10: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

1010

1600 1700 2100 2600 2800 3600 3700 Total* Design

New Applications1 9/30/2004

55,402 63,923 71,778 97,380 77,651 56,738 65,005 508,878 18,451

New Applications1

9/30/200562,644 72,697 76,529 115,585 94,425 70,354 83,225 586,580 24,056

Overall Pending Applications2

9/30/200495,006 105,447 102,440 138,822 137,458 101,097 108,039 809,323 27,599

Overall Pending Applications2

9/30/2005107,647 120,767 117,728 167,721 159,687 117,045 130,168 932,300 37,607

TC Application InventoryTC Application Inventory

1 “New Application inventory” is the number of new applications designated or assigned to a technology center awaiting a first action.

2 “Overall Pending Application inventory” is the total number of applications designated or assigned to a technology center in an active status. Includes new applications; rejected awaiting response; amended; under appeal or interference; suspended; reexams and allowed applications awaiting grant publication.

*Total inventory includes applications not assigned to a particular TC, awaiting processing either pre- or post-examination.

Page 11: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

1111

Pendency AchievedPendency Achieved

05

1015202530354045

Corps 1600 1700 2100 2600 2800 2900 3600 3700

First Action Pendency Overall Pendency

Target 30.2 MonthsTarget 30.2 Months

Target 21.3 MonthsTarget 21.3 Months

Page 12: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

Patent QualityPatent Quality(Shared Responsibility)(Shared Responsibility)

Page 13: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

1313

Quality of Products – FY 05Quality of Products – FY 05

Fiscal Year 2005

FY 04 1600 1700 2100 2600 2800 3600 3700Desig

nFY 05 FY 05

Target

Patent In-Process

Examination Compliance

Rate1*

82.0% 81.7% 82.9% 88.1% 84.7% 90.9% 84.4% 86.6% 94.3% 86.2% 84.0%

Patent Allowance Error Rate2*

5.32% 4.88% 6.46% 3.56% 2.25% 4.43% 4.94% 6.43% 1.6% 4.55% 4.0%

*Compliance and error rates as measured by OPQA. *Compliance and error rates as measured by OPQA. 1Compliance is the percent of office actions reviewed and found to be free of any in-process examination deficiency (an error that has significant adverse impact on patent prosecution).

2Patent allowance error rate is the percent of allowed applications reviewed having at least one claim which is considered unpatentable on a basis for which a court would hold a patent invalid. “Allowance” occurs before a patent is issued, so these errors are caught before any patent is actually granted.

Page 14: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

1414

Percent of Allowed Applications Percent of Allowed Applications with Material Defectwith Material Defect

0.00%

1.00%

2.00%

3.00%

4.00%

5.00%

6.00%

7.00%

Corps 1600 1700 2100 2600 2800 2900 3600 3700

Target 4%Target 4%

Page 15: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

Re-WorkRe-Work

Page 16: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

1616

Technology Centers Rework* StatisticsTechnology Centers Rework* Statistics

* Rework first actions are those actions that are in a Continuing (CONs and CIPs), RCE, CPA or 129(a) applications (excludes Divisionals).

FY 2002 FY 2003 FY 2004 FY 2005TC

Summary% FAOM Rework

% FAOM Rework

% FAOM Rework

% FAOM Rework

1600 36.4% 39.7% 40.3% 42.4%1700 25.2% 26.9% 27.1% 28.0%2100 23.9% 24.0% 24.6% 28.2%2600 24.8% 24.1% 24.3% 25.4%2800 19.1% 22.0% 24.9% 24.1%3600 17.7% 21.2% 23.1% 28.5%3700 22.2% 25.1% 24.0% 28.1%

UPR 23.2% 25.3% 26.1% 28.3%

Page 17: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

Hiring andHiring and

Retention Retention

Page 18: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

1818

Hires and AttritionsHires and Attritions

1600 1700 2100 2600 2800 3600 3700 Corps Design

FY 04 Hires 75 35 115 116 31 26 45 443 15

FY 04 Attritions 30 26 58 82 58 43 39 336 4

FY 05 BOY Examiner Staff

417 440 563 658 742 422 439 3681 72

FY 05 Hiring (10/1/05) 101 58 225 169 184 91 131 959 19

FY 05 Attrits (10/1/05) 42 39 93 92 54 55 50 425 10

FY 05 Hiring Goal 100 35 200 150 160 90 125 860 20

New Hires as a Percent of Examiner Staffing in the TC

24% 13% 40% 26% 25% 22% 30% 26% 26%

Page 19: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

1919

0.00%

2.00%

4.00%

6.00%

8.00%

10.00%

12.00%

14.00%

TC1600

TC1700

TC2100

TC2600

TC2800

TC2900

TC3600

TC3700

Corps

FY 05 Attrition of Average StaffFY 05 Attrition of Average Staff

Page 20: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

Pendency ProjectionsPendency Projections

Page 21: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

Pendency Reduction Action Plan

10.0

20.0

30.0

40.0

50.0

1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010

Fiscal Year

Pe

nd

en

cy

Historic Without Strategic Plan

Page 22: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

Pendency Reduction Action Plan

10.0

20.0

30.0

40.0

50.0

1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010

Fiscal Year

Pen

den

cy

Historic Without Strategic Plan 1,000 Hires & Low Attrits

Page 23: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

Pendency Reduction Action Plan

10.0

20.0

30.0

40.0

50.0

1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010

Fiscal Year

Pen

den

cy

Historic Without Strategic Plan 1,000 Hires & Low Attrits Plus Claims & Continuation Limits

Page 24: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

Pendency Reduction Action Plan

10.0

20.0

30.0

40.0

50.0

1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010

Fiscal Year

Pe

nd

en

cy

Historic Without Strategic Plan 1,000 Hires & Low Attrits Plus Claims & Continuation Limits Plus Patentability Report

Page 25: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005
Page 26: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

ProductionProduction

Page 27: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

2727

Page 28: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

Stats and StuffStats and Stuff

Page 29: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

2929

Continuation* Applications FiledContinuation* Applications Filed

0

5,000

10,000

15,000

20,000

25,000

2002

2003

2004

2005

1 Con 2 or more Con

*Straight Continuations 37 CFR *Straight Continuations 37 CFR §§1.53 (b)(1) – No Divisionals or CIPs – as of 10/23/051.53 (b)(1) – No Divisionals or CIPs – as of 10/23/05

Page 30: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

3030

RCE/CPA Filing RatesRCE/CPA Filing Rates

0

10,000

20,000

30,000

40,000

50,000

2002

2003

2004

2005

1 CPA/RCE 2 or more CPA/RCE

as of 10/23/05as of 10/23/05

Page 31: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

3131

Total Continuation Filing RatesTotal Continuation Filing Rates

0

10,000

20,000

30,000

40,000

50,000

2002

2003

2004

2005

1 CPA/RCE 1 Con* 2 or more CPA/RCE 2 or more Cons*

*Straight Continuations 37 CFR *Straight Continuations 37 CFR §§1.53 (b)(1) – No Divisionals or CIPs – as of 10/23/051.53 (b)(1) – No Divisionals or CIPs – as of 10/23/05

Page 32: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

3232

Total Continuation* Filing RatesTotal Continuation* Filing Rates

010,00020,000

30,00040,000

50,00060,00070,000

2002

2003

2004

2005

First Continuation Total Subsequent Continuations

*Continuation = Straight Continuations 37 CFR *Continuation = Straight Continuations 37 CFR §§1.53 (b)(1) + RCE + CPA – Not Divisionals or CIPs1.53 (b)(1) + RCE + CPA – Not Divisionals or CIPsas of 10/23/05as of 10/23/05

Page 33: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

3333

Continuation Filing RatesContinuation Filing Rates

0

20,000

40,000

60,000

80,000

100,000

120,000

FY80

FY82

FY84

FY86

FY88

FY90

FY92

FY94

FY96

FY98

FY20

00

FY20

02

FY20

04

Continuations (CON, CPA/RCE, DIV) CIPs

Page 34: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

3434

Continuation Filing RatesContinuation Filing Rates

0

20,000

40,000

60,000

80,000

100,000

FY80

FY82

FY84

FY86

FY88

FY90

FY92

FY94

FY96

FY98

FY20

00

FY20

02

FY20

04

Continuations (CON, CPA/RCE) CIPsAs of 10/24/2005As of 10/24/2005

Page 35: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

3535

Distribution of Independent Claims at FilingDistribution of Independent Claims at Filing

0%

10%

20%

30%

40%

50%1

2~3

4~6

7~10

11~2

0

21+

FY 2004 FY 2005

Page 36: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

3636

TC 1600 Distribution of Independent Claims TC 1600 Distribution of Independent Claims at Filingat Filing

0%

10%

20%

30%

40%

50%1

2~3

4~6

7~10

11~2

0

21+

FY 2004 FY 2005

Page 37: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

3737

Distribution of Total Claims at FilingDistribution of Total Claims at Filing

0%

10%

20%

30%

40%

1~10

11~2

0

21~2

5

26~3

0

31~4

0

41~5

0

51~6

0

61~1

00

101+

FY 2004 FY 2005

Page 38: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

3838

TC 1600 Distribution of Total Claims at TC 1600 Distribution of Total Claims at FilingFiling

0%

10%

20%

30%

40%

1~10

11~2

0

21~2

5

26~3

0

31~4

0

41~5

0

51~6

0

61~1

00

101+

FY 2004 FY 2005

Page 39: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

3939

Total Claims at Filing and IssueTotal Claims at Filing and Issue

0

3,000,000

6,000,000

9,000,000

FY 1990 FY 1999 FY 2004

0

8

16

24

Claims Filed Claims Issued Average Claims Filed

Page 40: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

4040

Distribution of the Number of Distribution of the Number of References Cited in ApplicationsReferences Cited in Applications

0500

1,000

1,5002,000

2,5003,0003,500

Non

e

1~3

4~5

6~10

11~2

0

21~3

0

31~4

0

>40

Page 41: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

Markush PracticeMarkush Practice

Page 42: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

4242

1.1. A cell adhesion protein of formula (1), A cell adhesion protein of formula (1),

A-(B)-(C)-(D)A-(B)-(C)-(D)nn-E-E

or a pharmaceutically acceptable or a pharmaceutically acceptable derivative thereof , wherein . . .derivative thereof , wherein . . .

Page 43: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

Accelerated ExaminationAccelerated Examination

Would You Like Your PatentWould You Like Your Patent

In 12 Months ?!?In 12 Months ?!?

Page 44: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

4444

Accelerated ExaminationAccelerated Examination

• Features of the proposed revision:Features of the proposed revision:

Move to the head of the lineMove to the head of the line Final Disposition within 12 monthsFinal Disposition within 12 months

Program for expedited Issuance of PatentsProgram for expedited Issuance of Patents e-file application and all follow on paperse-file application and all follow on papers Single InventionSingle Invention Limited Number of ClaimsLimited Number of Claims Patentability ReportPatentability Report Possible Interview before 1Possible Interview before 1stst Action Action Shortened Statutory PeriodShortened Statutory Period Enforcement of special status in the Corps Enforcement of special status in the Corps

Page 45: TC 1600 Biotechnology and Pharmaceutical Customer Partnership Meeting John Doll - Commissioner for Patents November 10, 2005

4545

Contact InformationContact Information

John Doll

Commissioner for Patents

e-mail: [email protected]

Phone: 571 272 8800